| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | VERSANT HCV RNA QUALITATIVE ASSAY |
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| Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
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| Regulation Number | 866.3170 |
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| Applicant | GEN-PROBE
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121 |
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| PMA Number | P020011 |
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| Date Received | 03/18/2002 |
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| Decision Date | 11/07/2002 |
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|
Reclassified Date
|
12/22/2021 |
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| Product Code |
MZP |
| Docket Number | 03M-0070 |
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| Notice Date | 02/28/2003 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE VERSANT HCV RNA QUALITATIVE ASSAY. THE DEVICE IS INDICATED FOR: THE VERSANT HCV RNA QUALITATIVE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION ASSAY FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM. THE VERSANT HCV RNA QUALITATIVE ASSAY IS INDICATED FOR USE WITH FRESH OR FROZEN SPECIMENS FROM THE FOLLOWING POPULATIONS: INDIVIDUALS WITH ANTIBODY EVIDENCE OF HCV INFECTION WITH EVIDENCE OF LIVER DISEASE, AND INDIVIDUALS SUSPECTED TO BE ACTIVELY INFECTED WITH HCV WITH ANTIBODY EVIDENCE, AND INDIVIDUALS AT RISK FOR HCV INFECTION WITH ANTIBODIES TO HCV. DETECTION OF HCV RNA IS EVIDENCE OF ACTIVE HCV INFECTION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S007 S005 S001 S006 S009 S008 S004 S002 S003 S012 S013
S015 S011 S010 S014 S016 |
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